A Phase 2 study to evaluate the Safety and Efficacy of CRN00808 for the treatment of acromegaly

Phase 1

• Conditions: Acromegaly; MedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-001833-42-SK
• Lead Sponsor: Crinetics Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-14
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Male and female subjects 18 to 75 years of age;
2.Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot
3.Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control;
4.Willing to provide signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1.Treatment naïve acromegaly subjects
2.Prior treatment with CRN00808
3.Pituitary surgery within 6 months prior to Screening or pituitary
radiation therapy at any time prior to the study entry (If a subject has
undergone pituitary radiation therapy =4 years prior to Screening and has had a documented IGF-1 =1.3×ULN within 2 years prior to Screening
OR if a subject has undergone pituitary radiation therapy between 3 and
4 years prior to Screening and has had a documented IGF-1 =1.3×ULN
within 1 year prior to Screening, the subject may be included in the
study);
4.History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years.
5.Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
6.Subjects with hepatitis B, Human Immunodeficiency Virus (HIV), or
hepatitis C infection. Subjects with previous hepatitis C infection that is
now cured may be eligible.
7.History of alcohol or substance abuse in the past 12 months
8.Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
9.Cardiovascular conditions or mediations associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities.
10.Subjects with symptomatic cholelithiasis
11.Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject’s safety or ability to complete the study
12.Subjects who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR (within the last 6 months);
13.Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg;
14.Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To determine the efficacy of CRN00808 in acromegaly subjects that are complete responders to parenteral octreotide LAR or lanreotide depot monotherapy;<br>2.To evaluate the safety and tolerability of CRN00808 in acromegaly subjects;<br>3.To evaluate the pharmacokinetics (PK) of CRN00808 in acromegaly subjects.<br><br>;Secondary Objective: NA;Primary end point(s): Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements =ULN);Timepoint(s) of evaluation of this end point: Week 13

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Change in IGF-1 levels;<br>2.Change in GH levels;<br>3.Change in symptoms of acromegaly as measured by total ASD score<br><br>;Timepoint(s) of evaluation of this end point: Week 13